FDA 510(k)

mCare® Powder Free Nitrile Black Examination Glove

Número K: K192444 · 2019-12-31

RequerenteMercator Medical (Thailand), Ltd.

Data da decisão2019-12-31

Código do produtoLZA

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

mCare® Powder Free Nitrile Black Examination Glove is the device name listed in this FDA 510(k) record. The listed applicant is Mercator Medical (Thailand), Ltd.. It received FDA 510(k) clearance on 2019-12-31 under 510(k) number K192444. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the mCare® Powder Free Nitrile Black Examination Glove?

mCare® Powder Free Nitrile Black Examination Glove is a medical device that received FDA 510(k) clearance on 2019-12-31. The listed applicant is Mercator Medical (Thailand), Ltd.. The 510(k) number is K192444.

When did mCare® Powder Free Nitrile Black Examination Glove receive FDA 510(k) clearance?

mCare® Powder Free Nitrile Black Examination Glove received FDA 510(k) clearance on 2019-12-31, under 510(k) number K192444.

Who is the listed applicant for mCare® Powder Free Nitrile Black Examination Glove?

The FDA 510(k) record lists Mercator Medical (Thailand), Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for mCare® Powder Free Nitrile Black Examination Glove?

The FDA product code for mCare® Powder Free Nitrile Black Examination Glove is LZA.

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Outros registros que listam Mercator Medical (Thailand), Ltd. como candidato(a)

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Dispositivos Relacionados (Código: LZA)

K261793Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color)Maxter Healthcare, Inc.K262542Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination Glove, Violet Blue Tested for Use With 32 Chemotherapy Drugs, Fentanyl & Gastric Acid Permeation Resistance ClaimTop Glove Sdn. Bhd.K260312Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim; Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric AcidGmp Medicare Sdn. Bhd.K261749Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl CitrateCardinalhealth K260794NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, FENTANYL CITRATE, XYLAZINE HCl, AND GASTRIC ACID. OCEAN COLORKossan International Sdn Bhd K262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam GlovesO&M Halyard, Inc.

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